Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria (DHART)
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| ClinicalTrials.gov Identifier: NCT02092766 |
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Recruitment Status :
Completed
First Posted : March 20, 2014
Last Update Posted : June 1, 2015
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Sponsor:
University of Oxford
Collaborator:
Kinshasa School of Public Health
Information provided by (Responsible Party):
University of Oxford
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Brief Summary:
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anaemia | Drug: artesunate Drug: quinine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 217 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: IV artesunate
Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
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Drug: artesunate |
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Active Comparator: IV quinine
Intravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total)
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Drug: quinine |
Primary Outcome Measures :
- Late onset anaemia [ Time Frame: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment ]Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42
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| Ages Eligible for Study: | 6 Months to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 6 months and ≤ 14 years
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
- Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
- Haemoglobin ≥5.0 g/dL
- Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
- Signed consent from the guardian/parents
Exclusion Criteria:
- Body weight ≤ 5 kg
- Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
- History of hypersensitivity or contraindication to quinine or artesunate
- A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
- Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
- Participation in another clinical trial
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092766
Locations
| Congo, The Democratic Republic of the | |
| Kinshasa School of Public Health | |
| Kinshasa, Congo, The Democratic Republic of the | |
Sponsors and Collaborators
University of Oxford
Kinshasa School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT02092766 |
| Other Study ID Numbers: |
KIMORU005 |
| First Posted: | March 20, 2014 Key Record Dates |
| Last Update Posted: | June 1, 2015 |
| Last Verified: | May 2015 |
Keywords provided by University of Oxford:
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malaria anaemia artesunate |
Additional relevant MeSH terms:
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Malaria Anemia Hematologic Diseases Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Artesunate Quinine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |